Safety and tolerability of 4 dose levels of intravitreal administration of iCo-007. [ Time Frame: At multiple points after injection up to and including 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the systemic pharmacokinetics of iCo-007 after intravitreal administration. To assess change in retinal thickness relative to baseline as determined by OCT. To assess change in best corrected visual acuity relative to baseline. [ Time Frame: At multiple points after injection up to and including 6 months ] [ Designated as safety issue: Yes ]

Subjects who have moderate to severe non-proliferative diabetic retinopathy (NPDR), as defined by ETDRS criteria, and diffuse DME within 300 microns from the center of the macula in the study eye (with or without cystoid changes) confirmed by FA.

Retinal thickness must be at least 250 microns in the central subfield, as shown by OCT

Woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening (serum). Both men and women are required to practice an adequate method of birth control

Able and willing to sign an approved informed consent form and return for all scheduled study visits

Exclusion Criteria:

Subjects with macular or perimacular edema secondary to an etiology other than diabetes mellitus

Subjects who have any additional ocular disease or condition which could compromise treatment safety, visual acuity or interfere with assessment of the macular edema, such as ocular inflammation, amblyopia, anterior ischemic optic neuropathy, media opacity, cataract

Subjects who had intraocular surgery, photocoagulation, intravitreal or subfoveal injection, topical or systemic steroids or who received any experimental treatment as part of another clinical trial within the last 3 months of the study start (in case of Anecortave within the last 6 months, any panretinal photocoagulation prior to study start)

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00886808